Triathlon 5540-A-201Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327014969), received between Oct 23, 2019 and Oct 23, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryOct 23, 2019Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THE PATIENT'S LEFT KNEE WAS REVISED DUE TO FEMORAL LOOSENING. THE FEMORAL COMPONENT WITH STEM, 3 AUGMENTS, AND LINER WERE REVISED TO ANOTHER FEMORAL COMPONENT WITH STEM, 3 AUGMENTS AND A LINER. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE LINER. REP PROVIDED PRIMARY AND REVISION USAGE AND REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 9226596 ↗
• InjuryOct 23, 2019Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THE PATIENT'S LEFT KNEE WAS REVISED DUE TO FEMORAL LOOSENING. THE FEMORAL COMPONENT WITH STEM, 3 AUGMENTS, AND LINER WERE REVISED TO ANOTHER FEMORAL COMPONENT WITH STEM, 3 AUGMENTS AND A LINER. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE LINER. REP PROVIDED PRIMARY AND REVISION USAGE AND REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 9226594 ↗